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Phase 1
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Methods: Patients will undergo percutaneous needle biopsies from either primary or
metastatic sites to obtain tumor tissue. Patients in whom sufficient tumor mRNA has been
amplified by PCR to transfect the assigned dendritic cell dose will undergo leukapheresis
and peripheral blood mononuclear cells will be cultured in vitro for 7 days with GM-CSF and
IL-4 to generate precursor derived dendritic cells. Dendritic cells will then be
cryopreserved for later use. On the day the patient returns to receive his infusion (weeks
0, 2, and 4) the dendritic cells will be thawed, reconstituted, and transfected with
amplified total tumor mRNA. Patients will receive a total of 3 treatments consisting of
combined I.V. and I.D. injections, each on study week 0, 2, and 4. Repeat leukapheresis will
be performed 2 weeks after the last dose to determine immune function. PSA levels will be
measured prior to the start of treatment and 2 weeks following the last infusion. Patients
who do not receive therapy due to a failure to produce sufficient RNA or dendritic cells
will be replaced in order to assess toxicity.

Data Analysis: 1. To determine the short and long term toxicities associated with
administration of tumor RNA dendritic cells in patients with metastatic prostate cancer. 2.
To determine feasibility of dendritic cell vaccine generation according to the proportion of
patients for whom sufficient cells are generated to provide treatment. 3. To determine the
cellular immune response to intravenous infusion of tumor RNA dendritic cells. 4. To measure
the PSA response of patients with metastatic prostate cancer to intravenous infusion of
tumor RNA dendritic cells.

Inclusion Criteria:

- The patient has a histologic or clinically confirmed prostate adenocarcinoma (Stage
D1-D3 metastatic with regional lymphatic, bone, visceral, or soft tissue metastases).
(Transitional cell and small cell carcinomas of prostate origin are excluded.)

- The patient has a karnofsky performance status greater than or equal to 70%.

- Estimated life expectancy > 6 months

- The patient has adequate hematologic function with: WBC>=3000mm3, Hemoglobin>=9mg/dl,

- The patient has adequate renal and hepatic function with: serum creatinine < 2.5mg/dl
bilirubin < 2.0 mg/dl

- The patient has adequate coagulation parameters with: PT = 11.3-13.3 sec PTT =
20.1-32.9 sec

- For patients who receive medical gonadal androgen suppression, the patient may
continue hormonally ablative therapy with LHRH analogues only (i.e. Gosereline or
Leuprolide). Testosterone level must be <50 mg/l.

- For patients who receive oral nonsteroidal antiandrogen therapy (i.e.flutamide or
bicalutamide) and experience a rising PSA: a 4 week period of observation must be
completed following discontinuation of the nonsteroidal antiandrogen prior to entry.

- The patient has the ability to understand and provide signed inform consent that
fulfills Institutional Review Board guidelines.

- The patient has the ability to return to Duke University Medical Center for adequate
follow-up as required by this protocol.

Exclusion Criteria:

- The patient is receiving concurrent chemotherapy, radiation therapy, or
immunotherapy. There must be at least 4 weeks (12 weeks if prior therapy included
89-Strontium) between any prior therapy and study entry. Patients must have recovered
from all acute toxicities from prior treatment.

- The patient has previously irradiated or new CNS (central nervous system) metastases.
(Pre-enrollment head CT is not required if not indicated by clinical signs or

- The patient has a history of autoimmune disease such as, but not restricted to,
inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis,
scleroderma, or multiple sclerosis.

- The patient has a serious intercurrent chronic or acute illness such as pulmonary
(asthma or COPD) or cardiac (NYHA class III or IV) or hepatic disease or other
illness considered by the P.I. to constitute an unwarranted high risk for
investigational drug treatment.

- The patient has a serious intercurrent chronic or acute illness such as pulmonary
(asthma or COPD) or cardiac (NYHA class III or IV) or hepatic disease or other
illness considered by the P.I. to constitute an unwarranted high risk for
investigational drug treatment.

- The patient has a medical or psychological impediment to probable compliance with the

- The patient has a concurrent second malignancy other than non-melanoma skin cancer,
or controlled superficial bladder cancer.

- The patient has an active acute or chronic infection, including symptomatic urinary
tract infection, HIV, or viral hepatitis.

- The patient is receiving oral or steroid therapy (or other immunosuppressive agents
such as azathioprine or cyclosporine A). There must be 6 weeks between
discontinuation of any steroid therapy and study enrollment.

- The patient has inadequate peripheral vein access to perform leukapheresis.

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Johannes Vieweg, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University


United States: Federal Government

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms



Duke University Medical Center Durham, North Carolina  27710